BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD HYBRID GLENOID BASE 4MM D BASE 4MM

    MDR report key: 9186506 · Received October 14, 2019

    Report

    Report Number
    0001825034-2019-04638
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 21, 2019
    Report Date
    June 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT AS THE ISSUE WAS DUE TO PATIENT FALL.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RADIOGRAPHS WERE PROVIDED, HOWEVER NOT REVIEWED AS: ALL 3 IMAGES APPEAR TO BE POST REVISION (REVERSE TOTAL SHOULDER) AND WILL THEREFORE NOT BE SENT TO MMI FOR REVIEW. THESE POST REVISION IMAGES WILL NOT AID IN THE INVESTIGATION FOR INSTABILITY THAT LEAD TO THE CONVERSION OF ANATOMIC TO REVERSE TOTAL SHOULDER. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE DETERMINED TO BE HUMAN FACTORS: PATIENT FALL. IT IS STATED THAT PATIENT WAS MEDICATED TO ASSIST SLEEPING. PATIENT WENT TO THE TOILET UNASSISTED AND FELL OVER. THE SHOULDER DISLOCATED AND RUPTURED THE REPAIR OF THE SUBSCAPULARIS WHICH WAS DONE DURING THE PRIMARY PROCEDURE. PATIENT ALSO NOTED TO HAVE PARKINSON'S DISEASE WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT AS THE ISSUE WAS DUE TO PATIENT FALL.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: 113046, VERSA-DIAL 46X24X47 HUM HEAD, LOT # 271630, CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # UNKNOWN, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 146550, CATALOG #: 113632, COMP PRIMARY STEM 12MM MINI, LOT # 362610. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL DID NOT RETURN IT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04647. NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER ANTROPLASTY APPROXIMATELY A MONTH AGO. SUBSEQUENTLY, THE PATIENT IS BEING REVISED FOR DISLOCATION AND RUPTURED SUBSCAPULARIS AFTER A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980920 MD HYBRID GLENOID BASE 4MM D BASE 4MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 460880

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R